Episealer® Knee System IDE Clinical Study

NAActive, not recruitingINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

June 18, 2020

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2028

Conditions
Degenerative Lesion of Articular Cartilage of Knee
Interventions
DEVICE

Episealer Knee System

The Episealer Knee System is comprised of individualized endoprosthetic resurfacing implants and implantation tools (Episealer Toolkit). The implants are designed to replace the articulating surface which has been damaged due to femoral knee chondral and osteochondral defects.

PROCEDURE

Microfracture

Microfracture is a minimally invasive surgical technique developed to repair defects in articular cartilage and reduce pain in the knee joint. Microfracture techniques are described in the orthopedic literature and are performed arthroscopically.

Trial Locations (13)

10117

Universitatsmedizin Berlin Charite, Berlin

10128

Plancher Orthopaedics & Sports Medicine, New York

20149

Orthocentrum Hamburg, Hamburg

38305

Helios Clinical Research, Jackson

43202

Ohio State University, Columbus

70121

Ochsner Sports Medicine Institute, New Orleans

75254

North Texas Medical Research Institute, Dallas

85284

Physicians Research Group, Tempe

91942

Horizon Clinical Research, La Mesa

07601

Hackensack University Medical Center, Hackensack

B3H 2E1

QEII Health Sciences Center, Halifax

CV2 2DX

University Hospital Coventry and Warwickshire NHS Trust, Coventry

Unknown

University Hospital Southampton NHS Foundation Trust, Southampton

Sponsors
All Listed Sponsors
collaborator

MCRA

INDUSTRY

lead

Episurf Medical Inc.

INDUSTRY